GENESIS II 71421548Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010512512), received between Jun 1, 2018 and Oct 3, 2024 — classified as 2 injuries.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A TKA SURGERY THAT HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED KNEE INFECTION. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON AN UNKNOWN DATE, IN WHICH ONE (1) GII CR DEEP FLEX ISRT S7-8 11M WAS EXCHANGED, AND THE INFECTED KNEE WAS WASHED OUT. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20358431 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION OF THE POLY INSERT.

  Patient problems: Joint Dislocation

  MAUDE report 7562591 ↗